Addressing Cervical Cancer Disparity in South Florida: CBPR in Action

University of Miami1 site in 1 country602 target enrollmentJanuary 2015

ConditionsCervical Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cervical Cancer
Sponsor: University of Miami
Enrollment: 602
Locations: 1
Primary Endpoint: Number of Participants Completing a Self-sampling Test
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study will test the significance of community health worker (CHW) participation by comparing self-sampling provided by a community health worker and self-sampling provided by mail. The study will enroll 700 participants in communities that lack access to medical care in South Florida.

Registry

clinicaltrials.gov

Start Date

January 2015

End Date

August 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

University of Miami

Responsible Party

Principal Investigator

Erin Kobetz-Kerman

Associate Professor

University of Miami

Eligibility Criteria

Inclusion Criteria

•Haitian, Hispanic, or African American
•Ages 30-65 years
•Report not having had a pap smear in the last three years live in the cities of Miami/Little Haiti, Hialeah or unincorporated Southern Miami-Dade

Exclusion Criteria

•Women who report having had a hysterectomy
•Women who have a history of cervical cancer
•Women who plan to move outside of Miami-Dade county during the next six months
•Women who are enrolled in any other cancer prevention/outreach related study
•Adults unable to consent
•Individuals who are not yet adults (infants, children, teenagers)
•Pregnant women
•Prisoners

Outcomes

Primary Outcomes

Number of Participants Completing a Self-sampling Test

Time Frame: 2 to 6 months

The primary outcome is having had a self-sampling done since the initial evaluation. Participants who test negative will be encouraged to rescreen while Participants who test positive for HPV will be navigated to appropriate follow-up care. The CHWs will follow up with participants who do not return the kit within 60 days.

Secondary Outcomes

Proportion of Change in Cervical Cancer Knowledge Among Participants(Baseline, 6 months)
Proportion of Participants With a Change in Access to Care(Baseline, 6 months)